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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bandage, liquid
510(k) Number K895819
Device Name MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
Applicant
MEDI-TECH, INC.
26 COURT ST.
BROOKLYN,  NY  11242
Applicant Contact HERBERT A PERRY
Correspondent
MEDI-TECH, INC.
26 COURT ST.
BROOKLYN,  NY  11242
Correspondent Contact HERBERT A PERRY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/29/1989
Decision Date 11/02/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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